In May 2022, the United States Food and Drug Administration (FDA) issued a Final Guidance, Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide. The guidance is focused specifically on small entities and helping them better understand the Final Rule, “Importation of Prescription Drugs,” published on October 1, 2020, effective November 30, 2020. As a reminder, the Final Rule only covers the importation of prescription drugs from Canada.
Who Can Import?
Under the Final Rule, Section 804 of the FD&C Act will be implemented through time-limited Section 804 Importation Programs (SIPs), which are reviewed and authorized by the FDA but managed (and potentially co-sponsored) by states or Indian Tribes, and in certain circumstances, by pharmacists or wholesale distributors. Under an authorized SIP, an importer – which must be a licensed pharmacist or wholesale distributor and U.S. owner of an eligible prescription drug at the time of entry into the United States – imports eligible prescription drugs. Additionally, the Importer’s pharmacist or wholesale distributor license (if issued by a state and not the FDA) must be issued by a State that is a SIP Sponsor or Co-Sponsor and the license must be in effect/active and in good standing with the licensor.
What Can Be Imported?
The guidance also covers what prescription drugs are eligible for importation, stating that a SIP sponsor must specify the eligible prescription drugs and that in order to be eligible, a drug must be approved by the Health Canada’s Health Products and Food Branch (HPFB) and it must have HPFB-approved labeling when marketed in Canada. Additionally, an eligible prescription must also meet the conditions in an FDA-approved new drug application or abbreviated new drug application (except it does not need required U.S. labeling when marketed in Canada).
The guidance also lists some drugs products that are excluded from importation eligibility, including controlled substances, biological products, infused drugs (including peritoneal dialysis solutions), drugs that are inhaled during surgery, drugs that are injected intravenously (into a vein), intrathecally (into the spinal fluid), or intraocularly (into the eye), drugs that are subject to a risk evaluation and mitigation strategy (REMS), and drugs that are not subject to certain provisions of the Drug Supply Chain Security Act.
Importation Requirements
According to the guidance, once a SIP proposal has been authorized by the FDA, the Importer must submit a Pre-Import Request to FDA at least 30 calendar days before the scheduled date of arrival or entry for consumption of a shipment containing an eligible prescription drug covered by the SIP, whichever is earlier. Drugs cannot be imported under this program until the FDA has given formal notification to the Importer that its Pre-Import Request has been granted. Additionally, imports can only come through the port of entry authorized by the FDA.
The Importer or its authorized customs broker is required to electronically file an entry for consumption in the Automated Commercial Environment or other electronic data interchange system authorized by CBP for each eligible prescription drug imported or offered for import into the United States.
Post-Importation Requirements
Importation requirements do not stop once the product is in the United States. Each SIP Sponsor is required to provide FDA with data and information about its SIP, including its cost savings to American patients. Importers are also required to submit adverse event, field alert, and other reports to a drug’s manufacturer and to the FDA. Additionally, if the FDA or any SIP participant determines that a recall is warranted, the SIP Sponsor is responsible for effectuating the recall. SIP Sponsors and other SIP participants must also agree to submit to audits of their books and records and inspections of their facilities as a condition of participation in a SIP.
As always, the guidance document just outlines the FDA’s current thinking and does not establish any rights nor is it binding on the FDA or the public. Additional information from the FDA on importing drugs from foreign markets can be found here.